TSO is the raw material of an active pharmaceutical ingredient, intended for treatment of autoimmune or allergic diseases.
The use of parasite material for medical treatment of inflammatory bowel disease (IBD) is described e.g. in U.S. Pat. No. 6,764,838.
The cause of inflammatory bowel disease (IBD) appears to involve both genetic and environmental factors. Current theories suggest that IBD results from an abnormal immune response to intestinal bacteria, initiated by unknown causes. IBD is common in industrialized countries where helminthic colonization is rare. Conversely, it is rare in regions of the world where most people have worms. Helminths could be beneficial in many autoimmune or allergic diseases because of their unique capacity to decrease hyper-reactive immune responses. In support of this idea, helminths reduce intestinal inflammation in both mice and man.
Members of helminth genus Trichuris are intestinal round worms (whipworms) with favorable characteristics for therapeutic use. Trichuris suis, the porcine whipworm, is genetically related to Trichuris trichiura, the human whipworm, but it has been shown experimentally to colonize humans only briefly without causing disease. The ova of T. suis can be produced using specific pathogen-free pigs, i.e. pigs free of infections with specified pathogens, and processed to assure absence of biological contaminants. For any production of TSO there are strict tolerances regarding the particle contamination and microbial activity of the solution used as a media:
1) The isolation process should ensure a particle contamination of the solution beyond 2% or 1% counted as numbers.
2) The isolation process should ensure that other parasite eggs are eliminated.
3) The microbial profile should fulfill the requirements for an oral administration containing raw material of natural origin under category 3B of the European Pharmacopoeia.
4) The media used for the storage should allow the development of the egg from un-embryonated (non-infective) to embryonated (infective) eggs.
5) The media should preferably not hold antibiotics or other chemicals, which may cause allergic reactions in potential patient.
6) The media used for the storage should allow for further long time storage (3-5 yrs) without affecting the infectivity of the TSO to facilitate an extended shelf life of a medicinal product.
7) The method should be applicable for the high quantity recovery of eggs.